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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00702299 |
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin and paclitaxel and giving them in different ways may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal pemetrexed when given together with intraperitoneal cisplatin and paclitaxel in treating patients with stage III ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: paclitaxel Drug: pemetrexed disodium Procedure: biologic sample preservation procedure Procedure: high performance liquid chromatography Procedure: mass spectrometry Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Open Label Trial of Alimta® Plus Cisplatin and Paclitaxel Given Intraperitoneally (IP) as First Line Treatment for Women With Stage III Ovarian Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of pemetrexed disodium.
Patients receive pemetrexed disodium intraperitoneally (IP) on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. At least 10 patients are treated at the maximum-tolerated dose (MTD).
Whole blood samples and tumor tissue specimens are obtained from patients at baseline and banked for future DNA, RNA, and protein studies related to prediction of disease progression and treatment resistance. Plasma and intraperitoneal fluid samples may also be collected from patients treated at the MTD for pharmacokinetic analysis of plasma concentrations of pemetrexed disodium by high-performance liquid chromatography (HPLC) or mass spectrometry-HPLC.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or pathologically confirmed ovarian epithelial carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Concurrent ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) with short elimination half-lives allowed provided ≥ 1 of the following criteria is met:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
Tucson, Arizona, United States, 85724-5024 | |
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 |
Study Chair: | Setsuko K. Chambers, MD | University of Arizona |
Principal Investigator: | David S. Alberts, MD | University of Arizona |
Study ID Numbers: | CDR0000597792, UARIZ-07-0638-04, UARIZ-SRC-18183, LILLY-UARIZ-07-0638-04, UARIZ-BIO07074 |
Study First Received: | June 19, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00702299 |
Health Authority: | Unspecified |
stage III ovarian epithelial cancer recurrent ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer |
Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Dental Caries Genital Diseases, Female Cisplatin Peritoneal Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Abdominal Neoplasms Recurrence Fallopian Tube Neoplasms Fallopian Tube Diseases Folic Acid Pemetrexed Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms Peritoneal Neoplasms Fallopian tube cancer Endocrinopathy |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists |
Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |